FDA Class I UDI Submission Deadline
FDA Class I
Class I devices and devices that have not been classified into class I, class II or class III that are required to be labeled with a UDI code, must submit product data to the FDA’s GUDID by September 24, 2022 (moved from September 24, 2020). FDA announced a two-year shift of the enforcement of this compliance date on June 30, 2020.
Class I Basic UDI Account:
- Simple step-by-step guidance for registration
- Validation and acknowledgment
- Submission meets all technical components of CFR Part 11 requirements
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